SafeSheath® II 667470-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20802526532645), received between Aug 14, 2024 and Aug 14, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K122084); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  WE ARE CURRENTLY EXPERIENCING TWO ISSUES WITH THE ADELANTE SHEATH. ONE IS THAT WHEN USING THE SHEATH IN THE HOSPITAL, AS SHOWN IN THE ATTACHED VIDEO. IT DOES NOT TEAR EASILY, OR THE SILICONE VALVE KEEPS GETTING STUCK AND NEEDS TO BE CUT WITH SCISSORS TO REMOVE IT. IT IS OCCURRING IN MANY HOSPITALS, WITH A FREQUENCY OF 8/10 CASES, AND IT IS MORE COMMON IN 7FR. I WOULD LIKE TO KNOW HOW WE SHOULD HANDLE THE ISSUE OF THE SHEATH NOT TEARING. SECONDLY, THE CUSTOMER STATED THAT THE ACTUAL SIZE DOES NOT MATCH THE DRAWING PROVIDED BY OSCOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

• Z-2680-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
• Z-2679-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
• Z-2678-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
• Z-1467-2021 · Feb 22, 2021 · Terminated
  AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheter